Ing. Ebrahem Njar

Angestellt, Regulatory Affairs Accounts Manager, Medical Regulations Gate - MRG

Dubai, Vereinigte Arabische Emirate

Fähigkeiten und Kenntnisse

MDD
SFDA
Medical Device Registration
ISO 9001
MS Office

Werdegang

Berufserfahrung von Ebrahem Njar

  • Bis heute 5 Jahre und 6 Monate, seit Jan. 2019

    Regulatory Affairs Accounts Manager

    Medical Regulations Gate - MRG

    Key Responsibilities: Handling the registration of the medical devices, IVDs, and Procedure Packs for the manufacture under the account. Reviewing the documents provided by the manufacturer and ensuring that they are obedient to the European Jurisdiction (CE), the United State Judication (FDA), or the Australian Judication (TGA).

  • 8 Monate, Juni 2018 - Jan. 2019

    Regulatory Affairs Specialist

    Medical Regulations Gate - MRG

    Main Responsibilities: Ensure that our Client’s products comply with the regulations/ legislation of the region where they want to register them. Create, compile and maintain regulatory documentation, databases, and policies and share knowledge and expertise with the team. Prepare Submission for new product licenses and monitor and set timelines for License variations and renewals approvals to strict deadlines.

  • 6 Monate, Jan. 2018 - Juni 2018

    Field Service Engineer

    Medical Innovation Trading LLC

    As a service engineer my responsibility included maintenance, installation, support and troubleshooting of various medical equipment Such as: endoscopy, laparoscopy, heart lung machine, patient warming and cooling system and many other more. Also coordinating with our customers and partner and documenting all our activity wither they are installation, PPM, CM.

  • 4 Monate, Aug. 2017 - Nov. 2017

    Service Engineer

    Al Sharq Healthcare

    as training of the Biomedical department of Al Sharq healthcare, the training included: - Assistant in responding to any pending request regarding corrective maintenance in all the department in the hospital and medical center. - Documentation of every single medical equipment in all the hospital departments and managing their periodic preventive maintenance and any corrective maintenance if needed plus supervising external engineers when ever they are installing or providing CM.

Ausbildung von Ebrahem Njar

  • 2013 - 2017

    Bachelor of Science in Biomedical Engineering

    Ajman University

Sprachen

  • Arabisch

    Muttersprache

  • Englisch

    Fließend

  • Deutsch

    Grundlagen

  • Französisch

    Grundlagen

Interessen

DJing

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